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Bady Bahaa El Mahalawy

Quality Assurance Supervisor at Global Napi Pharmaceuticals

Dokki, Giza, Egypt

Work Experience

  • QMS ManagerFull Time

    Jamjoom Pharma

    May 2022 - Present -3 yrs, 4 months

    Egypt

    • Compliance OfficerPart Time

      Ramco for import and export

      Apr 2021 - Jan 2022 -9 months

      • Job Details:Develop and implement legal compliance program Create internal controls, monitor adherence Evaluate business activities to assess compliance risk Set plans to manage a crisis or compliance violation Collaborate with external auditors Create ABAC system with its control and monitoring measurements
    • Quality and Compliance officerPart Time

      Ramco Import and Export

      Nov 2019 - Jan 2022 -2 yrs, 2 months

      Egypt , Cairo

      • Job Details:Planning, organizing, directing, and controlling the auditing and monitoring function for the company. Identify risk to which the company is exposed or can realistically be expected to be exposed. Examine and evaluate of the adequacy and effectiveness of the internal control system. Ensure that each function has fit-for-purpose policies and procedures that ensure compliance with laws, regulations and payment scheme operating regulations and standards to ensure high quality customer service, data security and other business imperatives. Achieves Compliance operational objectives by contributing information and analysis to strategic plans and reviews; preparing and completing action plans; Conduct internal audits for all company departments according to standards, rules and regulations. Risk and control committee member. Responsible for customer complain handling and ensuring that the proper corrective actions were taken to prevent repeatability of non-compliance. Evaluates the performance and monitor the achievement of the KPIs, targets and objectives. Use the Statistical process control tools to analyze the data and recommends for actions according to the findings of the analysis. Implementing production, productivity, quality, and customer-service .standards, identifying and resolving problems; completing audits; determining system improvements; implementing changes. Responsible Monitor, Implementing and improving the calibration programs. Recommends changes-in procedures, standards, test methods and equipment to improve quality. Create, manage and verify the conformity of all documents regarding the quality system. Research, train, and assist in compliance with Government, third party, and customer requirements and compliance with Good Manufacturing Practices. Assists in managing, maintaining documentation, testing, and final release of in-process hold and rework products as well as final release of finish good products for shipments Contributes the training department on defining the training needs for employees. Trains QA employees and plant employees on Quality Policy. Issues reports to board. Support, and comply with all quality management systems, continuous improvement programs, food safety, employee safety, preventative maintenance programs. Follow all company policies and procedures. Ensuring compliance with all related standards ex: ISO 9001, ISO 14001, CQM, PCI CP, Rules, Regulations and governmental laws. Ensuring that a quality management system is implemented and maintained Ensuring that relevant customer complaints are dealt with effectively Ensure that warehouse operations are compliant with GDP/ GMP standards and instructions
    • Quality and compliance officerPart Time

      Ramco Pharm

      Nov 2019 - Jan 2022 -2 yrs, 2 months

      Egypt , Cairo

      • Job Details:Planning, organizing, directing, and controlling the auditing and monitoring function for the company. Identify risk to which the company is exposed or can realistically be expected to be exposed. Examine and evaluate of the adequacy and effectiveness of the internal control system. Ensure that each function has fit-for-purpose policies and procedures that ensure compliance with laws, regulations and payment scheme operating regulations and standards to ensure high quality customer service, data security and other business imperatives. Achieves Compliance operational objectives by contributing information and analysis to strategic plans and reviews; preparing and completing action plans; Conduct internal audits for all company departments according to standards, rules and regulations. Risk and control committee member. Responsible for customer complain handling and ensuring that the proper corrective actions were taken to prevent repeatability of non-compliance. Evaluates the performance and monitor the achievement of the KPIs, targets and objectives. Use the Statistical process control tools to analyze the data and recommends for actions according to the findings of the analysis. Implementing production, productivity, quality, and customer-service .standards, identifying and resolving problems; completing audits; determining system improvements; implementing changes. Responsible Monitor, Implementing and improving the calibration programs. Recommends changes-in procedures, standards, test methods and equipment to improve quality. Create, manage and verify the conformity of all documents regarding the quality system. Research, train, and assist in compliance with Government, third party, and customer requirements and compliance with Good Manufacturing Practices. Assists in managing, maintaining documentation, testing, and final release of in-process hold and rework products as well as final release of finish good products for shipments Contributes the training department on defining the training needs for employees. Trains QA employees and plant employees on Quality Policy. Issues reports to board. Support, and comply with all quality management systems, continuous improvement programs, food safety, employee safety, preventative maintenance programs. Follow all company policies and procedures. Ensuring compliance with all related standards ex: ISO 9001, ISO 14001, CQM, PCI CP, Rules, Regulations and governmental laws. Ensuring that a quality management system is implemented and maintained Ensuring that relevant customer complaints are dealt with effectively Ensure that warehouse operations are compliant with GDP/ GMP standards and instructions
    • Education

      • MBA in Business adminstiration

        Arab Academy for Science, Technology and Maritime Transport (AAST)

        Jan 2022 - Jan 2024 - 2 yr

      • Bachelor's Degree in pharmacy

        Ain Shams University (ASU)

        Jan 2011 

      Skills

      • Microsoft Office
      • Microsoft excell
      • Quality Assurance
      • quality
      • Auditing
      • Validation
      • Compliance
      • HVAC Systems
      • Water Treatment
      • PMP
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      Languages

      • English

        Fluent

      Training & Certifications

      • Project Execution: Running the Project

        Google·2024
      • Project Planning: Putting It All Together

        Google·2022
      • Project Initiation Starting a Successful Project

        Google·2022
      • GMP Auditing

        USAID·2022
      • Kaizen Approach - Lean Methodology for Continuous Improvement

        Alison·2022
      • The 5S System - Lean Methodology on Workplace Optimization and Housekeeping

        Alison·2022
      • Problem Solving and Critical Thinking Skills

        Alison·2022
      • Strategic Management - Decision Making Processes and Tools

        Alison·2022
      • Understanding and implementing ISO 26000

        Millennium Company·2022
      • Internal auditors training according to ISO9001:2015 &ISO19011:2018.

        Millennium Company·2022
      • Understanding and implementing ISO 9001.

        Millennium Company·2022
      • Understanding and implementing ISO 37001.

        Millennium Company·2022
      • ISO Management System Audit Techniques and Best Practices

        Alison·2022
      • Training of Trainers - training methods

        Alison·2022
      • Lean six sigma yellow belt

        Alison·2022
      • GMP Deviation ,root cause analysis and CAPA

        Alison·2022
      • Data integrity and computer system validation

        USAID·2021
      • Foundations of project management

        Google·2021
      • Heating ,ventilation and Air conditioning (HVAC) systems

        USAID·2021
      • Qualification

        USAID·2021
      • Quality Risk Management

        USAID·2021
      • Validation

        USAID·2021
      • Water Systems

        USAID·2021
      • Advanced GMP training program

        EDA·2021
      • Anti Bribery /Anti corruption

        GNP·2020
      • Human Resources Diploma

        Alison·2015
      • FUNDAMENTAL ENTREPRENEURIAL CONCEPTS FOR STARTUP VENTURES

        AUC·2012
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